Vaccine Development and Manufacturing

Arranta Bio will use Cytiva’s FlexFactory single-use manufacturing platform to produce mRNA vaccines.

The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.

A report by international regulators reviews the effectiveness of current COVID-19 vaccines against the omicron variant.

The agreeement will add to Merck KGaA’s LNP and mRNA capabilities.

The agreement expands Pfizer’s access to LNP formulation technology for mRNA vaccines and therapeutics.

With this investment into Yapan Bio, Piramal Pharma adds new technologies and capabilities in large molecules, including vaccines and gene therapies, to its global offering.

Fareva plans to use blow-fill-seal equipment and ApiJect’s prefilled injector technology to create fill/finish capacity in France.

Sanofi’s acquisition of Origimm Biotechnology will add to its pipeline of vaccine candidates for treating acne.

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.

The companies are testing their existing vaccines against the new variant of concern and are pursuing variant-specific versions.

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.

Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.

Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.

EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.

Moderna’s new facility is expected to produce 500 million vaccine doses per year.

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.

The agency’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine.

The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.

Researchers in China report test results for a microneedle patch for COVID-19 vaccine delivery.

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

New data finds J&J COVID-19 vaccine and booster to provide increased protection against COVID-19.

The topline data from Pfizer and BioNTech’s trial suggests that a 10 µg vaccine is safe and effective among the 5 to 11 age group.

Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

Moderna’s newest insights include an overall efficacy review, a study on breakthrough infections, and a study on long-term immunity.

The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.

Moderna’s new single-dose vaccine will be a booster for both COVID-19 and the flu.

Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.

Models of biopharmaceutical processes can be used for speeding development and improving process control.